SPIC Frequency After Surgical Treatment of Peri-implantitis

Supportive Peri-implant Care Frequency After Surgical Treatment of Peri-implantitis - a Multi-center Randomized Clinical Trial

The leading hypothesis behind this study is that a 3-month frequency of supportive peri-implant care (SPIC) recalls after surgical therapy of implants affected by severe peri-implantitis yields better results when compared to a 6-month frequency. Thus, the primary aim of this randomized clinical trial is to compare 2 different frequencies of SPIC recalls (3 and 6 months) after surgical treatment of severe peri-implantitis in terms of treatment success (absence of implant loss, probing pocket depth (PPD) ≤ 5 mm at all aspects, bleeding on deep probing ≤1 site/implant, no suppuration at all aspects, bone loss <0.5 mm) at early follow-up (1-year) and implant survival at the 5-year examination. Secondarily, this randomized clinical trial aims to assess the effects of the 2 different frequencies over clinical attachment levels around remaining teeth.

Study Overview

• Status: Not yet recruiting
• Conditions: Peri-Implantitis
• Intervention / Treatment: Procedure: 3-month supportive peri-implant care (SPIC); Procedure: 6-month supportive peri-implant care (SPIC)

• Study Type: Interventional
• Enrollment (Estimated): 152
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mario Romandini; Email: mario.romandini@gmail.com
• Study Contact Backup: Name: Giacomo Baima, PhD; Phone Number: 011 6331546; Email: giacomo.baima@unito.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Any patient aged 18 years or more, who has at least one implant affected by severe peri-implantitis, and able to sign an informed consent form will be potentially eligible for this trial. Severe peri-implantitis will be defined as the presence of a peri-implant probing pocket depth [PPD] ≥ 6 mm in at least 1 site of the implant, bleeding and/or suppuration on deep probing [dBoP and/or dSoP, respectively] and radiographically documented marginal bone loss > 3 mm (Carcuac et al. 2016; Romandini et al. 2022) on implants in function by at least 12-months. In the absence of baseline radiographs, implants had to present a bone level >3 mm (Romandini et al. 2021b).

Patients fulfilling the above-mentioned inclusion criteria will not be included in the study if they appear to be unable to attend the study-related procedures (including the long-term follow-up visits) or if one or more of the following systemic or local exclusion criteria are detected during the enrolment phase.

Systemic primary exclusion criteria:

• systemic diseases (e.g. uncontrolled diabetes mellitus) or chronic use of medications (e.g. corticosteroids, bisphosphonates) likely to influence the outcome of therapy or which contraindicates the study procedures;
• smoking >10 cigarettes;
• pregnant or nursing women.

Local primary exclusion criteria:

• history of peri-implantitis treatment on the eligible implants in the previous 6 months;
• hopeless implants (>80% of bone loss/level).

A secondary inclusion criterion will be applied 1-month after surgery:

- absence of peri-implant abscess on the implants to be included.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 3-month frequency of supportive peri-implant care (SPIC); SPIC provided at a 3-month frequency starting from the 1-month re-evaluation after surgical treatment of peri-implantitis.	Procedure: 3-month supportive peri-implant care (SPIC); SPIC including update on smoking status, evaluation of the patient's adherence to self-performed oral hygiene procedures, full-mouth supra-gingival instrumentation around teeth, repeated sub-gingival instrumentation on sites presenting a PPD >4 mm with BoP/SoP or a PPD≥6 mm, supra-marginal instrumentation around implants, using an erythritol air abrasive system and interdental brushes, sub-marginal instrumentation on implants with BoP after deep probing by an erythritol air abrasive system and/or ultrasonic scaler provided at a 3-month frequency after surgical treatment of peri-implantitis.
Active Comparator: 6-month frequency of supportive peri-implant care (SPIC); SPIC provided at a 6-month frequency starting from the 1-month re-evaluation after surgical treatment of peri-implantitis.	Procedure: 6-month supportive peri-implant care (SPIC); SPIC including update on smoking status, evaluation of the patient's adherence to self-performed oral hygiene procedures, full-mouth supra-gingival instrumentation around teeth, repeated sub-gingival instrumentation on sites presenting a PPD >4 mm with BoP/SoP or a PPD≥6 mm, supra-marginal instrumentation around implants, using an erythritol air abrasive system and interdental brushes, sub-marginal instrumentation on implants with BoP after deep probing by an erythritol air abrasive system and/or ultrasonic scaler provided at a 6-month frequency after surgical treatment of peri-implantitis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment success - criterion 1 (yes/no)	Absence of implant loss, probing pocket depth ≤ 5 mm at all aspects, deep bleeding/suppuration on probing ≤1 site/implant, bone loss <0.5 mm	1 year
Implant loss (yes/no)	Implant removed, or mobile, or radiographic evidence of complete loss of osseointegration.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant loss (yes/no)	Implant removed, or mobile, or radiographic evidence of complete loss of osseointegration.	1 and 3 years
Treatment success - criterion 1	Absence of implant loss, probing pocket depth ≤ 5 mm at all aspects, deep bleeding/suppuration on probing ≤1 site/implant, bone loss <0.5 mm	3 and 5 years
Treatment success - criterion 2 (yes/no)	Absence of: implant loss, bone loss >1 mm and surgical re-treatments.	1, 3, and 5 years
Plaque presence (yes/no)	Presence of plaque (binary - presence/absence in at least 1 site)	1, 3 and 5 years
Plaque extent	Plaque extent (continuous - number of sites per implant: 0-6 sites)	1, 3 and 5 years
Probing pocket depth (mm)	Probing pocket depth (continuous - assessed at the deepest site per implant)	1, 3 and 5 years
Bleeding on deep probing (yes/no)	Bleeding on deep probing (binary - presence/absence in at least 1 site)	1, 3 and 5 years
Soft-tissue level margin (mm)	Peri-implant soft-tissue margin level from a constant fixed reference point (continuous - greatest implant level increase among the 6 sites)	1, 3 and 5 years
Keratinised mucosa height (mm)	Keratinized mucosa height (continuous - midbuccal aspect)	1, 3 and 5 years
Bleeding on superficial probing	Bleeding on superficial circumferential probing (categorical - highest implant level value: 0=no sBoP, 1= isolated bleeding spots; 2=confluent red line on margin; 3=heavy or profuse bleeding)	1, 3 and 5 years
Suppuration (yes/no)	Suppuration on deep probing (binary - presence/absence in at least 1 site).	1, 3 and 5 years
Modified Bleeding Index	Modified Bleeding Index after profound probing (categorical - highest implant level value: 0=no dBoP; 1=isolated bleeding spots; 2=confluent red line on margin; 3=heavy or profuse bleeding)	1, 3 and 5 years
Radiographic outcomes	Taking into account the worst site-specific (between mesial and distal) change: bone level change, bone gain >0.5 mm, bone loss >0.5 mm.	1, 3 and 5 years
Patient- and clinician- esthetic appreciation	Assessment on a 100 mm visual analogue scale (VAS) of both patient- and clinician- esthetic appreciation and overall patient satisfaction.	Assessed at 1, 3 and 5 years
Total SPIC duration (months)	Total supportive peri-implant care duration in months , number of sub-marginal re-instrumentations at study implants during SPIC appointments, compliance to SPIC regimen, number of surgical retreatments, and rate of adverse events	Assessed at 1, 3 and 5 years
Number of sub-marginal re-instrumentations at study implants	Number of sub-marginal re-instrumentations at study implants during SPIC appointments	Assessed at 1, 3 and 5 years
Compliance to SPIC regimen (yes/no)	Compliance to SPIC regimen according to patient randomisation	Assessed at 1, 3 and 5 years
Number of surgical retreatments	Number of surgical retreatments performed on the study implant during the study time	Assessed at 1, 3 and 5 years
Rate of adverse events	Rate of adverse events occurred during the study time, both dependent and independent of the study procedures	Assessed at 1, 3 and 5 years
Full-mouth plaque score (0-100)	A full-mouth periodontal examination around the remaining dentition (6 sites per tooth/implant) will be performed assessing plaque (presence/absence)	1, 3, and 5 years
Full-mouth bleeding score (0-100)	A full-mouth periodontal examination around the remaining dentition (6 sites per tooth/implant) will be performed assessing Bleeding on Probing (presence/absence),	1, 3, and 5 years
Clinical attachment level around remaining teeth	Probing pocket depth (PPD) and recession (REC) (negative values when the CEJ is located subgingivally, positive otherwise). Clinical attachment levels (CAL) will be calculated by summing PPD and REC values for each site. Patient-level incidence of clinical attachment loss >2 mm around teeth will be evaluated as a further outcome.	1, 3, and 5 years
Chairside aMMP-8 assay (positive/negative)	Chairside active matrix metalloprotease-8 (aMMP-8) assay will be conducted at the study implant site. Positivity will be determined using a threshold value of ≥20 ng/mL.	1, 3, and 5 years
Molecular analysis in the peri-implant crevicular fluid	Cytokines expressed in the peri-implant crevicular fluid will be monitored as additional outcomes to study the mechanistic interplays involved in the potential different clinical response between groups.	1 month, 6 months, 1, 3 and 5 years
Microbiological analysis	Shotgun metagenomics will be used to monitor the microbiological profile associated to the clinical condition.	1 month, 6 months, 1, 3, and 5 years

Collaborators and Investigators

• Sponsor: University of Turin, Italy
• Collaborators: Ege University

Study record dates

Study Major Dates

• Study Start (Estimated): January 20, 2025
• Primary Completion (Estimated): September 15, 2031
• Study Completion (Estimated): September 15, 2031

Study Registration Dates

• First Submitted: December 9, 2024
• First Submitted That Met QC Criteria: December 31, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 31, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Peri-Implantitis
• Other Study ID Numbers: SPIC Multi-center

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No